510(k) K151529
K151529 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator". The FDA issued a decision of Substantially Equivalent on February 11, 2016. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2016
- Date Received
- June 8, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device Class
- Class I
- Regulation Number
- 862.1680
- Review Panel
- CH
- Submission Type